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目的:比较培门冬酶(PEG-Asp)和左旋门冬酰胺酶(L-Asp)治疗儿童急性淋巴细胞白血病(ALL)的疗效与安全性,为ALL患儿化疗方案的选择提供依据。方法:收集2010年3月至12月青岛大学医学院附属医院小儿血液科收治的分别采用PEG-Asp或L-Asp行强化治疗的ALL患儿(PEG-Asp组和L-Asp组)的临床资料并进行分析。2组患儿除均行含长春新碱、吡柔比星和泼尼松的强化治疗外,PEG-Asp组给予PEG-Asp 2500 U/m2,肌内注射,1次/2周,连用2次;L-Asp组给予L-Asp6000 U/m2,静脉注射,隔日1次,共8次。2组患儿均定期检测血常规、凝血功能、血淀粉酶、尿淀粉酶、血糖和肝功能,化疗前后行骨髓象检查,记录病情缓解时间及住院时间,观察疗效与不良反应。按照2003年美国国立癌症研究所制定的不良事件通用术语标准(3.0版),将不良反应分为0~4级。结果:PEG-Asp组男20例,女20例,中位年龄6.3岁。L-Asp组男33例,女27例,中位年龄6.7岁。强化治疗前及强化治疗后随访期内骨髓象检查结果显示2组患儿病情均完全缓解。PEG-Asp组完全缓解时间[(13.2±2.0)个月]与L-Asp组[(13.9±1.8)个月]的差异无统计学意义,PEG-Asp组平均住院时间[(11.5±7.1)d]短于L-Asp组[(18.5±4.9)d],差异有统计学意义(P<0.05)。PEG-Asp组和L-Asp组皮肤试验阳性率分别为10.0%和21.7%,差异无统计学意义。强化治疗期间,PEG-Asp组和L-Asp组分别有1例和4例患儿出现过敏反应,表现为皮疹或口唇及喉头水肿或腹泻。2组患儿均出现凝血功能障碍,白细胞、中性粒细胞和血小板减少,血红蛋白降低,均出现丙氨酸转氨酶、总胆红素、总胆固醇、尿素氮和血糖的升高及低蛋白血症。各级不良反应分布的差异均无统计学意义。结论:L-Asp与PEG-Asp在儿童急性淋巴细胞白血病强化治疗中均较安全有效,出现的不良反应种类与级别类似,但PEG-Asp具有用药次数少、患儿住院时间短的特点。
Objective: To compare the efficacy and safety of PEG-Asp and L-Asp in the treatment of childhood acute lymphoblastic leukemia (ALL), and to provide a basis for the selection of chemotherapy regimens in children with ALL. Methods: The clinical data of ALL children (PEG-Asp group and L-Asp group) who were treated with PEG-Asp or L-Asp in the pediatric department of hematology, Qingdao Medical University Hospital from March to December 2010 were collected. Data and analysis. In addition to the intensive treatment with vincristine, pirarubicin and prednisone, PEG-Asp group received PEG-Asp 2500 U / m2, intramuscular injection once a week for 2 weeks Times; L-Asp group given L-Asp6000U / m2, intravenous injection, every other day, a total of 8 times. Blood samples, blood coagulation, blood amylase, urine amylase, blood sugar and liver function were detected regularly in both groups. Bone marrow imaging was performed before and after chemotherapy. The time to remission and hospital stay were recorded. The curative effect and adverse reactions were observed. According to the 2003 National Cancer Institute developed a common terminology standard of adverse events (version 3.0), the adverse reactions are divided into 0 to 4 levels. Results: PEG-Asp group 20 males and 20 females, the median age of 6.3 years old. There were 33 males and 27 females in the L-Asp group, with a median age of 6.7 years. Intensive pre-treatment and intensive treatment during follow-up bone marrow examination showed that the two groups of patients with complete remission of disease. There was no significant difference in complete remission time between PEG-Asp groups ([13.2 ± 2.0] months] and L-Asp group ([13.9 ± 1.8] months] d] was shorter than L-Asp group [(18.5 ± 4.9) d], the difference was statistically significant (P <0.05). The positive rates of skin test in PEG-Asp group and L-Asp group were 10.0% and 21.7% respectively, with no significant difference. During intensive treatment, allergic reaction occurred in 1 case in PEG-Asp group and 4 cases in L-Asp group, showing rash or lip and laryngeal edema or diarrhea. Coagulation dysfunction, leukopenia, neutrophils and thrombocytopenia, and decreased hemoglobin were observed in both groups, with elevated alanine aminotransferase, total bilirubin, total cholesterol, urea nitrogen, and blood glucose and hypoproteinemia . Adverse reactions at all levels of distribution of the differences were not statistically significant. CONCLUSION: L-Asp and PEG-Asp are safe and effective in intensive treatment of childhood acute lymphoblastic leukemia. The types and levels of adverse reactions are similar, but PEG-Asp has the characteristics of less medication and shorter hospitalization time.